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Completed

NCT Number: NCT03669744

Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital

Trigeminal neuralgia is defined according to the third edition of the International Classification of Headache Disorders (ICHD-3) criteria. Chronic pain can have a major impact on the quality of life. First-line treatments are anti-epileptics, and surgical treatments are also possible according to several approaches. Sometimes the pain is resistant to these therapies. In this indication, sensory blocks may have a therapeutic impact but their place is not clear. In France, there are formalized expert recommendations on "loco regional analgesia and chronic pain", from 2013. Several adjuvants to local anesthetics have been studied for acute and chronic pain. CLONIDINE and DEXAMETHASONE are of greatest interest in increasing block duration and reducing opioid consumption. The investigators report the case of 21 patients, treated by a trigeminal block from 2014 to 2018, suffering from a resistant trigeminal neuralgia. After a first consultation, the diagnosis is confirmed, an information is done and an appropriate support is established. The sensory block is performed as an outpatient care. It consists in a peri-neural injection of a mixture of LEVOBUPIVACAINE 5%, CORTIVAZOL 3.75mg / 1.5mL (or BETAMETHASONE 7mg / 1ml) and CLONIDINE (1μg / kg). Standard precautions are respected and patients are monitored in the recovery room after the procedure. The efficacity is evaluated before the exit and a follow-up is done within 15 days. The level of satisfaction expressed by the patients seems to be globally high. The investigators wish to evaluate statistically the impact of the trigeminal blocks, in terms of improvement of the quality of life. This retrospective study, by its procedure, does not change the management of patients.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Major patients with trigeminal neuralgia resistant to usual treatments, according to the ICHD-3β criteria
  • treating by one or more trigeminal nerve blocks
  • at the peri operative pain management center of Limoges University Hospital
  • between 2014 and 2018

Exclusion criteria

  • Not consent
  • Another type of facial block during the previous year.
  • Unavailable medical data
  • Deceased patient

Treatment and study plan

Telephone survey

Other

a telephone survey will be conducted at 21 patients with trigeminal neuralgia resistant to usual treatments, according to the ICHD-3β criteria treating by one or more trigeminal nerve blocks at the peri operative pain management center of Limoges University Hospital between 2014 and 2018.

Primary outcomes

  1. Change of the quality of life from baseline to day 15 after baseline

    Time frame: Day 0, Day 15

    Percentage of patients with improvement of more than 50% in quality of life, mesured with the 'Medical Outcome Study Short Form 12', from baseline (day 0 = just before the block) to day 15. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.

Secondary outcomes

  1. Change in pain level just before and after the block assessed by a numerical scoring scale

    Time frame: Day 0, Day 15

    Average value of the Numerical Rating Scale immediately before, after and at day 15 after the block. Zero represents 'no pain at all' whereas ten represents 'the worst pain ever possible'

  2. Neuropathic criteria of pain just before and after the block assessed by DN4

    Time frame: Day 0

    Average value of the DN4 score before and after the block. DN4 questionnaire helps estimate the likelihood of neuropathic pain. The maximum score is 10. The threshold value for the diagnosis of neuropathic pain is 4.

  3. Duration of the block

    Time frame: Day 0

    Number of days before covering an VAS justifying a new block

  4. Patient overall satisfaction assessed by a Numerical Rating Scale.

    Time frame: Day 0

    Average value of the Numerical Rating Scale. Zero represents 'not at all satisfied' whereas ten represents 'very satisfied'.

  5. Impact on analgesics consumption assessed by the dosage of analgesics

    Time frame: Day 0

    doses of analgesics compared to those usually delivered

  6. Side effects

    Time frame: Day 0

    To list side effects

  7. Return to work

    Time frame: Day 0

    For the patients concerned: yes / no

  8. Return to hobbies

    Time frame: Day 0

    For the patients concerned: yes / no

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: TRINEB ONE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2018
Registry last updated
Sep 25, 2019

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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